Clobutinol

• (±) -1 - (4- chlorophenyl ) -4 - dimethylamino -2, 3 - dimethylbutan -2-ol

R05DB03

Antitussive

Template: Infobox chemical / molecular formula search available

Clobutinol (original Trade Name: Silomat, Boehringer Ingelheim ) is a drug that as a cough suppressant ( antitussive ) was used. Clobutinol inhibits the cough center in the brain and relieves heavy chesty cough ( "dry" cough).

Mid-2008, ended the marketability for all Clobutinol -containing finished product after side effects were known at the heart at risk for life-threatening consequences. (see " From the launch to recall " )

• 2.1 Mechanism of action ( pharmacodynamics )

• 3.1 From the initial launch by the recall

Clinical information

Areas of application

Clobutinol was used in a dry, tickly cough.

Adverse effects (side effects)

Clobutinol was until his recall to be very well tolerated and safe drug.

In a yet to be fully published study in healthy subjects resulted in dose-dependent Clobutinol to a significant prolongation of the QT interval on the electrocardiogram that exceeds the currently accepted limits. By QT prolongation potentially life-threatening cardiac arrhythmias ( " torsades arrhythmias " ) may be caused. In the literature, there is currently a case of torsade arrhythmia. Also, a case of grand mal seizure after overdose could theoretically be associated with the effects on ECG.

Furthermore, single cases have been known of allergic reactions.

Pharmacological properties

Mechanism of action ( pharmacodynamics )

Clobutinol inhibits the cough center in the medulla oblongata (medulla oblongata ), thus reducing the frequency and intensity of coughing. For productive cough or verschleimtem the desired expectoration of mucus could be suppressed. Therefore Clobutinol was recommended only for use in a dry, tickly cough.

Other Information

From the introduction to the callback

Clobutinol was in the 1950s (now part of Boehringer Ingelheim) developed by Dr. Karl Thomae GmbH and the 1960/61, applied for a patent. In 1961 it was introduced in Germany under the name Silomat as medicines.

According to the manufacturer, more than 200 million patients have taken the often prescription drug available over 40 years. Even among experts was considered the drug to be safe. After becoming aware of the occurrence of torsade arrhythmia in a little boy the German Federal Institute for Drugs and Medical Devices ( BfArM) asked the manufacturers to explore Clobutinol to possible effects on the electrical conduction of the heart.

After presenting the study subjects, the BfArM ordered on 31 August 2007 to the suspension of admission for all Clobutinol -containing medicines. The decision of the BfArMs based on a benefit -risk assessment: although the risk of potentially life-threatening side effects is considered low, there are other medicines for the treatment of mild illness rather cough available. On the same day drew Boehringer Ingelheim all own Clobutinol containing medicinal world back from the market.

In October 2007, the recommendation of the Committee for Human Medicinal Products of the European Medicines Agency approval for all Clobutinol -containing medicines in the EU followed to revoke. A decision of the European Commission was implemented by the BfArM in June 2008.

Following the recall of Clobutinol has been speculated that it is - statistically speaking - it is established that many patients had died of Clobutinol. No one had suspected the cough medicine were considered safe, trigger incidents. The risk of occurrence of QT prolongation with life-threatening consequences was initially considered to be low. The boy, in which the arrhythmia torsades had occurred as a result of Clobutinoleinnahme, survived despite a pre-existing heart damage.